MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-PFO-3025

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported that a on (b)(6) 2023, a 30-25mm amplatzer talisman patent foramen ovale (pfo) occluder was chosen for implant, using a 09f amplatzer talisman delivery sheath.Patient had an atrial septal defect (asd) and pfo requiring closure.The pfo measurement was 15mm, it was decided to close the pfo whilst covering the asd, using a 30-25mm amplatzer talisman pfo occluder.During preparation, the device was released to allow an air bubble out of the loader and recaptured under saline.During this, the device had mushroomed slightly but seemed okay just before fully loading.Once in the patient, the right disc had deformed to a mushroom-like shape, and the disc would not reform despite wiggle tests.There was no angulation or kink noticed in the delivery system.There was no interaction with cardiac structures during deployment.The device was removed and when observed, the right disc still would not easily form a standard disc shape.A replacement 30-25mm amplatzer talisman pfo occluder was used to complete the procedure, utilizing the same delivery sheath.This device was prepped perfectly but again appeared to mushroom slightly before loading.However, it was decided to use the device.Once in place, the right disc had deformed to a mushroom-like shape.It was decided to release the device from the cable despite ongoing discussion.The implanter then attempted to gently push the deformed disc using a small catheter and the disc did form back into more of a disc shape at one side, though one side still remained slightly deformed.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of device deformity was reported.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from the field indicated that there was no angulation or kink noticed in the delivery system or interaction with cardiac structures.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note per the instructions for use, do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as superior vena cava (svc), pulmonary vein (pv), mitral valve (mv), coronary sinus (cs), aorta (ao)).

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18212533
• MDR Text Key: 329064283
• Report Number: 2135147-2023-05196
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 8817737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMPLATZER TALISMAN DELIVERY SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 85 KG